摘要
目的评价肠道病毒71型(Enterovirus 71,EV71)灭活疫苗(人二倍体细胞)上市后大规模接种的不良反应。方法选择湖北、浙江省6-71月龄儿童接种EV71疫苗,采用主动监测方式收集每剂疫苗接种后0-30d的不良反应,计算不良反应发生率。结果接种第1剂、第2剂疫苗分别纳入有效研究对象60115例、47313例,共收集到不良反应/事件2733例,总发生率为25.44‰;其中局部、全身反应发生率分别为2.93‰、15.20‰,≥3级局部、全身反应发生率分别为0.11‰、1.14‰。最常见的局部、全身反应分别为注射部位红(1.59‰)、发热(10.94‰)。结论本研究6-71月龄儿童接种EV71疫苗后30d内不良反应发生率低,未观察到新的罕见不良反应。
Objective To assess adverse reactions of inactivated enterovirus 71(EV71)vaccine(human diploid cell)after mass vaccination.Methods We selected 6-71-month-old children in Hubei and Zhejiang provinces and administered EV71 vaccine to consented subjects.We used active monitoring to collect all adverse events/reactions within 30 days of vaccination for calculating the incidence of adverse events/reactions.Results Among 60115 recruited subjects for the first dose of vaccine and 47313 for the second dose of vaccine,2733 adverse events/reactions were reported after vaccination,with an overall incidence rate of 25.44‰.The incidence was 2.93‰ for local reactions,and 15.20‰ for systemic reactions;the incidence rates for grade 3 or more local reactions and systemic reactions were 0.11‰and 1.14‰,respectively.The most common local reaction was redness(1.59‰),and the most common systemic reaction was fever(10.94‰).Conclusion The adverse reaction rate for EV71 vaccination was low among children aged 6-71 months within 30 days of vaccination;no new,rare adverse reactions were observed.
作者
赵志梅
王雷
邓燕
王四全
蒋蕊鞠
沈灵智
车艳春
Zhao Zhimei;Wang Lei;Deng Yan;Wang Siquan;Jiang Ruiju;Shen Lingzhi;Che Yanchun(Institute of Medical Biology,Chinese Academy of Medical Sciences and Peking Union Medical College,Kunming 650118,Yunnan,China;Hubei Provincial Center for Disease Control and Prevention,Wuhan 430079,Hubei,China;Zhejiang Provincial Center for Disease Control and Prevention,Hangzhou 310051,Zhejiang,China)
出处
《中国疫苗和免疫》
北大核心
2019年第5期557-561,575,共5页
Chinese Journal of Vaccines and Immunization
基金
中国医学科学院医学与健康科技创新工程服务“一带一路”战略先导科研专项(2017-I2M-B&R-16)
关键词
肠道病毒71型灭活疫苗
不良反应
主动监测
Inactivated enterovirus 71 vaccine
Adverse reaction
Active surveillance
